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Human Genes Can't Be Patented, Supreme Court Rules

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By Aditi Mukherji, JD on June 13, 2013 12:06 PM

In a first of its kind ruling on human gene patents, the U.S. Supreme Court unanimously decided that synthetically produced genetic material can be patented, but naturally occurring DNA extracted from the human body cannot, Reuters reports.

The Court's decision is a partial victory to biotechnology company Myriad Genetics Inc., which holds the patents in question.

But since the Court ruled that isolated human genes may not be patented, the rights group that challenged the patents came away with a win too.

A Myriad of Legal Issues

The case concerned Myriad's patents on the genes BRCA1 and BRCA2, which correlate with increased risk of hereditary breast and ovarian cancer.

The patents were challenged by scientists and doctors who argued Myriad's patents had a chilling effect on breast and ovarian cancer research, and that their ability to help patients was stifled.

The patented genes at issue were in the spotlight after Angelina Jolie underwent a preventive double mastectomy. In her op-ed for The New York Times, Jolie pointed out the dire need for women to obtain affordable access to genetic testing.

As previously discussed in FindLaw's Celebrity Justice blog, the price of the test -- often more than $3,000 -- was partly a product of Myriad's patent, putting it out of reach for some women. This is because Myriad filed patent infringement suits against others who conducted testing based on the gene.

As a result of the Court's decision, the price of the test is expected to fall, reports The New York Times.

No Patents for 'Products of Nature'

The core issue of the case, Association for Molecular Pathology v. Myriad Genetics, No. 12-398, was whether isolated human genes are "products of nature" that may not be patented or "human-made inventions" eligible for patent protection.

Myriad's discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify, Justice Clarence Thomas wrote for the Court.

"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated," Thomas explained. "It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes."

The Court rejected the Federal Circuit's ruling that protected a "finder's keepers" approach to isolated gene patents. Justice Thomas pointed out that discovery of an isolated gene, no matter how "groundbreaking, innovative or even brilliant," is not eligible for patent protection.

There are still ways for companies to make a profit from their research, Thomas added. For example, companies can still get patent protection for manipulating a gene to create something not found in nature.

Companies can also patent the methods of isolating human genes, just not the isolated genes themselves.

Unfortunately for Myriad, "the processes used by Myriad to isolate DNA were well understood by geneticists," Thomas wrote.

From the perspective of Sandra Park of the ACLU Women's Rights Project, the decision is a milestone lauding scientific discovery and patient care.

"Today, the court struck down a major barrier to patient care and medical innovation," she said. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."

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